Validation of a NICS Method Using the Culture Medium

NCT03879265 | Completed

• 1 other identifier: IBB11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium. The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy \[PGT-A\]) will be compared.

Conditions

Chromosome Abnormality; Abnormality

Keywords

Diagnosis; Reproduction; Chromosomal Endowment

Outcome Measures

Primary Outcomes (2)

• Presence of Mosaicism

  Presence of mosaicism

  At Day 5-6 after FIV

• Quality value of NICS DLRS

  Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)

  At Day 5-6 after FIV

Study Arms (1)

Study group

No intervention. Couples who come to the study center to carry out a PGT-A cycle will be selected. Only couples that will use their own gametes will be selected and the indication of PGT-A will be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations. The results of chromosomal status of the embryo will be compared using the NICS and the conventional invasive method (PGT-A).

Diagnostic Test: Noninvasive chromosome screening

Interventions

Noninvasive chromosome screening DIAGNOSTIC_TEST

Screening based on MALBAC-NGS technology

Study group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Couples who come to the study center to carry out a PGT-A cycle. Only couples that perform treatment using their own gametes will be selected and where the indication of PGT-A will be able to be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations.

You may qualify if:

• Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A).
• Embryonic cryopreservation.
• Informed consent signature

You may not qualify if:

• Embryo transfer without embryo freezing
• Embryonic block.
• Bad embryo quality.

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Embryo culture medium

MeSH Terms

Conditions

Chromosome Aberrations; Congenital Abnormalities; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Belén Lledo, PhD

  Instituto Bernabeu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 20, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

ES (1)